MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP V30 AUTO; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number 1111178

Device Problems Computer Software Problem (1112); Electromagnetic Compatibility Problem (2927)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/27/2020

Event Type  malfunction  

Event Description

The manufacturer received information alleging a ventilator inoperative condition occurred.There was no harm or injury reported.The ventilator was returned to the manufacturer for evaluation and the customer¿s complaint was confirmed.Error code e-46 was confirmed.There was secondary of blower and flow tube contamination (dust and dirt).The device's right-side panel.Blower, box mount, pressure tube, flow tube, pca and manifold was replaced to address the issue.It was later noted in a status update: the unit was placed on pmat code 036 due to software issues.The unit was scrapped.

• Brand Name: BIPAP V30 AUTO
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18336587
• MDR Text Key: 330613388
• Report Number: 2518422-2023-35877
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00606959049635
• UDI-Public: 00606959049635
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1111178
• Device Catalogue Number: 1111178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Initial Date Manufacturer Received: 02/27/2023
• Initial Date FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1